Job Description
– Executive, QC-QA Department: Quality Control (QCQA) Designation: Executive/Senior Executive

Experience:
3–4 Years Qualification: B.
Pharm / M.
Pharm / M.
Sc. Industry: Pharmaceutical / Biotechnology Job Responsibilities
• Handle QA Documentation and Quality Management System (QMS) activities.
• Draft, review, and maintain SOPs, STPs, TDSs, and Specifications.
• Manage Change Controls, Deviations, and CAPA activities from initiation to closure.
• Maintain and control quality documents through Document Management Systems (DMS).
• Review Batch Manufacturing Records (BMR) and other quality-related documents.
• Coordinate employee training and maintain training records through LMS.
• Prepare change comparison sheets and track QMS activities.
• Support internal and external regulatory audits,



including USFDA and EMA audits.
• Ensure compliance with cGMP, GDP, Data Integrity, and other applicable quality requirements.
• Coordinate with QC, QA, Production, Regulatory Affairs, and other cross-functional teams. Required Skills
• Hands-on experience in QA Documentation and QMS.
• Knowledge of Change Control, CAPA, and Deviation Management.
• Experience in SOP, STP, TDS, and Specification preparation and review.
• Knowledge of DMS, LMS, and BMR review.
• Exposure to regulatory audits such as USFDA / EMA.
• Understanding of cGMP, GDP, and Data Integrity requirements.

📌 Quality Assurance Specialist (Vapi)
🏢 Micro Crispr
📍 Vapi